合作式血小板功能分析（COOPERATIVE-PFA）：一项三臂随机对照试验。

COOPERATIVE-PFA: A Three-Arm Randomized Controlled Trial.

作者信息

Sochorová Veronika, Kunštátová Veronika, Osmančík Pavel, Duška František, Heřman Dalibor, Waldauf Petr, Povišer Lukáš, Karch Jakub, Znojilová Lucie, Filipcová Věra, Hozmanová Jana, Veselá Jana, Hozman Marek

机构信息

Department of Anesthesia and Intensive Care Medicine, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic (V.S., V.K., F.D., P.W.).

Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic (P.O., D.H., L.P., J.K., L.Z., V.F., J.H., J.V., M.H.).

出版信息

Circulation. 2025 Jul 22;152(3):150-159. doi: 10.1161/CIRCULATIONAHA.125.074427. Epub 2025 Apr 27.

DOI:10.1161/CIRCULATIONAHA.125.074427

PMID:40287932

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12272916/

Abstract

BACKGROUND

Deep analgosedation (DAS) or general anesthesia is mandatory for pulsed-field ablation of atrial fibrillation. In contrast to DAS, general anesthesia (conventional or total intravenous anesthesia [TIVA]) requires airway management. To find the optimal sedation regimen, this study compared ketamine-remimazolam DAS and propofol-opioid TIVA with propofol-opioid DAS, focusing on sedation-related adverse events.

METHODS

Patients indicated for atrial fibrillation catheter ablation were randomly assigned at a 1:1:1 ratio to: (1) DAS using intermittent propofol-opioid boluses (arm P), (2) continuous remimazolam-ketamine DAS (arm R), or (3) continuous propofol-opioid TIVA with secured airway (arm TIVA). Catheter ablation was performed using the FARAPULSE system (Boston Scientific, MA). The major exclusion criterion was obstructive sleep apnea syndrome. The primary end point was defined as a composite of hypoxemia, hypotensive, or hypertensive events requiring intervention or leading to procedure discontinuation. Secondary end points included hemodynamic instability events, procedure time, serious adverse events, and patient satisfaction.

RESULTS

One-hundred twenty-seven patients (mean age 62.9±10.3 years, 35.1% women, 47.2% with paroxysmal atrial fibrillation) were enrolled and randomized to the P (n=42), R (n=43), or TIVA (n=42) arms. The primary end point occurred in 85.7% of P patients, 27.9% of R patients, and 66.7% of TIVA patients (<0.001), driven by hypoxemia in the P arm (100% of patients with the primary end point) and by hypotension in the TIVA arm (100%). The R arm showed a similar distribution of hypoxemia (50%) and hypotensive (66.7%) events. No differences were observed in mean procedural time, rate of serious adverse events, and assessment of patient satisfaction.

CONCLUSIONS

In pulsed-field ablation procedures for atrial fibrillation, remimazolam-ketamine DAS was superior to propofol-opioid regimens (either boluses or continuous) and had the lowest risk of hypoxemia and hypotensive events. More than 80% of patients undergoing conventional propofol-opioid analgosedation experienced hypoxemia.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT06013345.

摘要

背景

对于房颤的脉冲场消融，深度镇痛镇静（DAS）或全身麻醉是必需的。与DAS不同，全身麻醉（传统麻醉或全静脉麻醉[TIVA]）需要气道管理。为了找到最佳的镇静方案，本研究比较了氯胺酮-瑞米唑仑DAS与丙泊酚-阿片类TIVA以及丙泊酚-阿片类DAS，重点关注与镇静相关的不良事件。

方法

拟行房颤导管消融的患者按1:1:1的比例随机分配至：（1）使用丙泊酚-阿片类间歇推注的DAS组（P组），（2）持续输注瑞米唑仑-氯胺酮的DAS组（R组），或（3）气道安全的持续丙泊酚-阿片类TIVA组（TIVA组）。使用FARAPULSE系统（波士顿科学公司，马萨诸塞州）进行导管消融。主要排除标准为阻塞性睡眠呼吸暂停综合征。主要终点定义为需要干预或导致手术中断的低氧血症、低血压或高血压事件的综合指标。次要终点包括血流动力学不稳定事件、手术时间、严重不良事件和患者满意度。

结果

127例患者（平均年龄62.9±10.3岁，女性占35.1%，阵发性房颤患者占47.2%）入组并随机分为P组（n = 42）、R组（n = 43）或TIVA组（n = 42）。主要终点在P组85.7%的患者、R组27.9%的患者和TIVA组66.7%的患者中发生（<0.001），P组主要由低氧血症导致（100%的主要终点患者），TIVA组主要由低血压导致（100%）。R组低氧血症（50%）和低血压（66.7%）事件的分布相似。在平均手术时间、严重不良事件发生率和患者满意度评估方面未观察到差异。